Abbott Laboratories Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
DES PLAINES, Ill., Aug. 9 /PRNewswire-FirstCall/ -- Abbott has received a supplemental Premarket Approval from the U.S. Food and Drug Administration for its recently introduced RealTime HIV-1 viral load test. The approval allows Abbott to market a number of enhancements to the test, including a new design feature that will give laboratories the flexibility to perform HIV-1 viral load tests with smaller amounts (0.6 mL) of blood plasma. Abbott markets the m2000(TM) system and a menu of tests throughout the world as part of a strategic alliance with Celera.
"It can be challenging to obtain blood samples from some people, particularly critically ill patients," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. "This improvement will give labs the ability to use a smaller sample size while still maintaining the highest sensitivity and precision of any HIV-1 viral load test. It's easier on the patient and at the same time better for the lab."
Initially approved in the United States on May 11, 2007, the RealTime test, based on real-time polymerase chain reaction (PCR) technology, is the most sensitive HIV-1 viral load test available and the only test of its kind validated to detect and quantitate (precisely measure) the common strains of HIV-1 as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes.
The Abbott assay has a broad dynamic range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA copies per mL, surpassing the standard of care in diagnostic sensitivity of 50 copies per mL. Also, unlike other assays, the Abbott RealTime HIV-1 test targets the highly conserved pol integrase region of the HIV-1 genome, giving the test its unique ability to detect and measure all known genetic variations of the virus.
"Because of what we now know about the emergence of variant strains of HIV-1 in the United States and other countries, it is critical for clinicians to monitor for non-B subtypes as well as group O and group N strains of HIV-1 in their patients," Stenzel said. "It is imperative that an assay with reliable subtype performance be used to guide antiretroviral therapy so as to not be lulled into thinking a patient is responding well to therapy when, in fact, they are not. The RealTime assay also correlates well with other viral load tests, which suggests that it is not necessary for physicians to reestablish a baseline viral load for their patients when changing to this test," he said.
The company also received supplemental approval to increase the testing capacity of the Abbott m2000 automated instrument for use with the RealTime HIV-1 viral load test. The enhanced system can process up to 96 specimens in a batch and 192 specimens in one laboratory shift. This represents the highest throughput available for an HIV-1 viral load test using real-time PCR technology.
"We're pleased to offer these important enhancements, which we believe reinforces the clinical advantages of the RealTime HIV-1 viral load test," said Stafford O'Kelly, president, Abbott Molecular.
Additional products in development in the United States for the Abbott m2000 system include assays for hepatitis C virus, hepatitis B virus, chlamydia and gonorrhea. The m2000 system and a full menu of infectious disease tests are available in the European Union as CE-marked products.
More About the Abbott RealTime HIV-1 Test
Quantitative measurements of HIV-1 levels in blood have greatly contributed to the understanding of the process by which the virus infection leads to disease and has been shown to be an essential parameter in prognosis and management of HIV infected individuals. Decisions regarding initiation or changes in antiretroviral therapy are guided by monitoring plasma HIV-1 levels or viral load, CD4-T cell count, and the patient's clinical condition. The goal of antiretroviral therapy is to reduce the virus in plasma to below detectable levels.
The RealTime test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
About Applera Corporation and Celera
Applera Corporation consists of two operating groups: Celera and the Applied Biosystems groups. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and is developing diagnostic products based on these markers as well as other known markers. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products, and is also developing new diagnostic products outside of this alliance. Through its genomics and proteomics research efforts, Celera is also discovering and validating therapeutic targets, and has established and is seeking strategic partnerships to develop therapeutic products based on these discovered targets. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which is referred to as "applied markets," such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of over $1.9 billion during fiscal 2006. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at http://www.celera.com.
Applera Corporation's Forward-Looking Statements
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements.
These factors include but are not limited to (1) uncertainty that the Abbott RealTime HIV-1 and HCV assays or the m2000 system will be accepted by the market, including the risk that these products will not be competitive with products offered by other companies; and (2) other factors that might be described from time to time in Applera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
About Abbott's Molecular Diagnostics Business
Abbott Molecular, a division of Abbott based in Des Plaines, Ill., is an emerging leader in molecular diagnostics -- the analysis of DNA, RNA and proteins at the molecular level. Abbott Molecular's instruments and tests provide physicians with critical information based on the early detection of pathogens and subtle, but key changes in patients' genes and chromosomes. They help physicians diagnose disease and infections earlier, select appropriate therapies and monitor disease progression. In addition to the RealTime HIV-1 viral load test and the Abbott m2000, Abbott Molecular's portfolio of products also includes innovative genomic tests for chromosome changes associated with congenital disorders and cancer, including the PathVysion(R) HER-2 DNA Probe Kit, a test used to help select women with breast cancer who could benefit from Herceptin(R) therapy, and UroVysion(TM), which detects genetic changes in bladder cells for aiding in the diagnosis of bladder cancer in patients with hematuria (blood in the urine) and for monitoring bladder cancer recurrence.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available at the company's Web site at http://www.abbott.com.
AbbottCONTACT: Media, Don Braakman, +1-847-772-3263, or +1-224-361-7246, orFinancial, Tina Ventura, +1-847-935-9390, both for Abbott